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Randomized Controlled Trial Examining the Effect of Small Versus Large Tuohy-type Epidural Needles on the Incidence and Severity of Postdural Puncture Headache
The purpose of this study is to determine the effect of 19g versus =\>18g traditional Tuohy-type epidural needles on the incidence and severity of postdural puncture headache (PDPH).
A headache is the most significant complication of dural puncture during epidural placement. This complication leads to longer hospital stays and many repeated visits to hospital for management. Women suffering from severe postdural puncture headache (PDPH) are often bedridden and unable to care for themselves or their babies.The efficacy of epidural blood patch as a "gold standard" therapy is over-estimated by the earlier, poor quality studies. The prevalence of dural puncture during epidural anesthesia using current techniques ranges from 0.03 to 6% in the literature. Of these patients, 70 to 80% will suffer from moderate to severe PDPH. Avoidance of dural puncture is always the goal. However, complete avoidance is unlikely using current techniques of needle placement. This study proposes another method of prevention (i.e., reducing the gauge of the epidural needles if it is shown to be suitable for continuous infusion in adults). Most of the risk factors for developing PDPH cannot be changed (e.g., younger age, female sex, low body mass index, history of migraines). However, epidural needle gauge is a modifiable risk factor. Evidence suggests that the use of smaller gauge epidural needles, like spinal needles, have the potential to reduce the incidence and severity of PDPH.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
British Columbia Women's Hospital and Health Centre
Vancouver, British Columbia, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
St. Joseph's Hospital
London, Ontario, Canada
Sunnybrook Health Sciences Centre at Women's College Hospital
Toronto, Ontario, Canada
Start Date
June 1, 2007
Primary Completion Date
December 1, 2009
Completion Date
December 1, 2009
Last Updated
June 9, 2022
1,081
ACTUAL participants
19g Tuohy-type epidural needle, 23g catheter
DEVICE
=> 18g Tuohy-type needle
DEVICE
Lead Sponsor
Sunnybrook Health Sciences Centre
Collaborators
NCT06444737
NCT07436403
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05262933